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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

Glass 1983.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 16% drop out after 2.5 years (study duration = 2.5 years). Natural losses; no losses due to any adverse effects; any differential group losses not assessable.
Participants 853 children analysed at 2.5 years (available at final examination).
 Age range at start: 7‐11 years (average = 9).
 Surfaces affected at start: 2.1 DFS.
 Background exposure to fluoride: water.
 Year study began: 1976.
 Location: USA.
Interventions FT (2 groups) versus PL 
 (both SMFP groups = 1000 ppm F).
School use/supervised, daily (appropriate toothpastes and toothbrushes also provided for home use).
 Abrasive system: IMP (main abrasive) in one SMFP and placebo toothpaste, Ca carbonate in the other SMFP toothpaste.
Outcomes 2.5yNetDFS increment ‐ (CA)cl+(ER)xr.
 Reported at 2.5 years follow up.
DFT.
CIR.
Notes Participants randomised (N = 1017); numbers by group NR.
 Baseline characteristics (age, DFS, DFT, SAR, TAR) 'balanced' (for DFT/DFS).
 Clinical (VT) caries assessment by two examiners (independently); diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by two examiners (independently); diagnostic threshold = ER. Results of one examiner chosen (findings consistent throughout).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure